Real-world experience of rituximab biosimilar GP2013 in rheumatoid arthritis patients naïve to or switched from reference rituximab.

Randomized controlled trials showed high comparability of biosimilar rituximab (bs-RTX) GP2013 to biologic originator RTX (bo-RTX). Data on effectiveness of switching from bo-RTX to bs-RTX, starting therapy with bs-RTX, and bs-RTX drug survival in real-world setting are sparse. To explore long-term drug effectiveness and survival of bs-RTX GP2013 in rheumatoid arthritis (RA) patients both naïve to and mandatory switched from bo-RTX, and to clarify reasons for treatment cessation. Retrospective observational cohort study including RA outpatient clinic patients treated with bs-RTX between 2018 and 2021 in Norway. Patients were examined and monitored using recommended measures for disease activity and patient-reported outcomes (PROs). For description of population medians and interquartile range were used. Difference between observation times was assessed with Signed-Rank test, drug survival with Kaplan-Meier survival analysis. Reasons for discontinuation were ascertained. Among 110 patients, at baseline, 88 were mandatory switched from bo-RTX and 22 were RTX-naïve. During 2-year follow-up, disease activity and PROs measures remained stable in switchers subgroup and improved in subgroup starting bs-RTX for the first time. Overall drug survival was 80.0% after 1 year and 57.7% after 2 years and was significantly higher in bs-RTX-switched than in bs-RTX-naïve patients (p = 0.036). Two most frequently reported reasons for drug discontinuation were remission (38.6%) and doctor's decision (27.1%). RA patients treated with bs-RTX had satisfactory treatment response and drug retention rates which supports equivalence of bs-RTX GP2013 to bo-RTX, both in patients naïve to and mandatory switched from bo-RTX.

Real-world evidence of the effectiveness and safety of generic tofacitinib in rheumatoid arthritis patients: a retrospective, single-centre analysis from Western India.

Generic tofacitinib has been available in India for more than a year and is widely used in rheumatoid arthritis (RA) therapy. There is scarce real-world data on its effectiveness and safety from India, especially given infection endemicity. We retrospectively analysed records (demographic and clinical information, haematology and biochemistry, adverse events) of patients prescribed generic tofacitinib from a single centre in Mumbai, India. Disease activity was calculated using the disease activity score-28 and erythrocyte sedimentation rate (DAS28-ESR) and other tools, and we used paired T-tests for significant response. We defined clinical tofacitinib failure as a composite outcome, including clinician's decision to change to an alternative disease-modifying anti-rheumatic drug (DMARD) or flare after self-withdrawal. We performed logistic regression and survival analysis for determinants of clinical failure. We reviewed records of 102 patients (92 female; median age: 53 years) with mean RA duration of 146 months. Thirteen had prior treatment with innovator tofacitinib. There was significant improvement in disease activity parameters at a mean duration of 186 days. No serious adverse events were reported; 4 patients had tuberculosis and 19 patients had mild COVID-19 while on treatment. Clinical failure was seen in 25 patients, and mean time to failure on survival analysis was 357 days. No baseline characteristic predicted clinical failure. Generic tofacitinib showed good effectiveness and a tolerable adverse effect profile, despite tuberculosis endemicity and COVID-19. Setting up registries would be valuable in gaining more data on generic tofacitinib. Key Points • There is scarce data from India regarding the use of tofacitinib in rheumatoid arthritis, despite widespread use. • In this retrospective analysis of 102 patients at a single centre, we found tofacitinib monotherapy was efficacious and tolerable. • Tuberculosis was detected in four and nineteen patients had mild covid.

Two-dose COVID-19 vaccination and possible arthritis flare among patients with rheumatoid arthritis in Hong Kong.

OBJECTIVES: To investigate the relationship between COVID-19 full vaccination (two completed doses) and possible arthritis flare. METHODS: Patients with rheumatoid arthritis (RA) were identified from population-based electronic medical records with vaccination linkage and categorised into BNT162b2 (mRNA vaccine), CoronaVac (inactive virus vaccine) and non-vaccinated groups. The risk of possible arthritis flare after vaccination was compared using a propensity-weighted cohort study design. We defined possible arthritis flare as hospitalisation and outpatient consultation related to RA or reactive arthritis, based on diagnosis records during the episode. Weekly prescriptions of rheumatic drugs since the launch of COVID-19 vaccination programme were compared to complement the findings from a diagnosis-based analysis. RESULTS: Among 5493 patients with RA (BNT162b2: 653; CoronaVac: 671; non-vaccinated: 4169), propensity-scored weighted Poisson regression showed no significant association between arthritis flare and COVID-19 vaccination ((BNT162b2: adjusted incidence rate ratio 0.86, 95% Confidence Interval 0.73 to 1.01); CoronaVac: 0.87 (0.74 to 1.02)). The distribution of weekly rheumatic drug prescriptions showed no significant differences among the three groups since the launch of the mass vaccination programme (all p values >0.1 from Kruskal-Wallis test). CONCLUSIONS: Current evidence does not support that full vaccination of mRNA or inactivated virus COVID-19 vaccines is associated with possible arthritis flare.